Introduction About MACITENT 10MG TABLET

MACITENT 10MG TABLET contains Macitentan which belongs to the group of medicines called Endothelin receptor antagonists. MACITENT 10MG TABLET is used alone/with other medicines to manage pulmonary hypertension in adults, which is a condition that occurs due to high blood pressure in pulmonary arteries (blood vessels that carry blood from heart to lungs).

MACITENT 10MG TABLET is not recommended for use in patients allergic to Macitentan, and/or soya. It is also not recommended for use in patients with liver disease or who have been tested with very high levels of liver enzymes in the blood.

Before taking MACITENT 10MG TABLET, inform your doctor if you have lung problems (such as pulmonary veno-occlusive disease), and/or kidney problems.

The most common side effects of taking MACITENT 10MG TABLET are anemia, headache, bronchitis (inflammation of the airways), edema (swelling of arms and feet), urinary tract infection, low blood pressure, and/or blocked nose. Consult your doctor if any of these symptoms worsen.

Uses Of MACITENT 10MG TABLET

• Manage pulmonary arterial hypertension in adults

How MACITENT 10MG TABLET Works

MACITENT 10MG TABLET works by blocking the action of endothelin hormone (chemical that cause vasoconstriction) which leads to relaxation and widening of blood vessel wall resulting in reduced pressure on the blood vessel wall and lower blood pressure thus managing pulmonary hypertension in affected individuals.

How to use MACITENT 10MG TABLET

Take MACITENT 10MG TABLET as advised by your physician. Swallow the medicine with a glass of water. Do not crush or chew the medicine. Your doctor will decide the correct dose and duration for you depending upon your age, body weight, and disease condition.

Side Effects Of MACITENT 10MG TABLET

How To Manage Side Effects

Headache:

If MACITENT 10MG TABLET causes headache, then take rest and drink plenty of fluids. Try to avoid drinking alcohol. Ask your doctor to recommend a painkiller. Headaches should usually go away after the first week of taking MACITENT 10MG TABLET. If it lasts more than a week or becomes severe, then consult and inform your doctor.

Warning & Precautions

Pregnancy

MACITENT 10MG TABLET is generally not recommended for use during pregnancy and in women planning for pregnancy.  Women of childbearing potential should use contraceptive measures and should consult doctor immediately if accidental pregnancy occurred while taking MACITENT 10MG TABLET since the medicine may cause harm to the unborn babies.

Breastfeeding

MACITENT 10MG TABLET is not recommended for use in breastfeeding women as it is not known whether the medicine may pass through breast milk. Consult your doctor before taking the medicine.

Driving and Using Machines

Do not drive or operate machines if you feel headache and/or low blood pressure after taking MACITENT 10MG TABLET.

Kidney

MACITENT 10MG TABLET should be used with caution in patients with kidney problems. Consult your doctor before taking MACITENT 10MG TABLET.

Liver

MACITENT 10MG TABLET is not recommended to use in patients with liver disease or who have been tested with very high levels of liver enzymes in the blood. Consult your doctor before taking MACITENT 10MG TABLET.

Allergy

Do not take MACITENT 10MG TABLET if you are allergic to Macitentan, soya, and/or any other ingredients of this medicine.

Lungs

MACITENT 10MG TABLET should be used with caution in patients with lung problems such as pulmonary veno-occlusive disease (obstruction of lung vein). Consult your doctor before taking the medicine.

Interactions

A. Drug-Drug interactions:

Before taking MACITENT 10MG TABLET, inform your doctor if you are taking any of the following medicine:

• antibiotics (used to manage bacterial infections) Ex. rifampicin, clarithromycin, telithromycin, ciprofloxacin, erythromycin
• medicine used to manage seizures (Ex. phenytoin)
• medicine used to manage depression and epilepsy (Ex. carbamazepine)
• herbal medicines used to manage depression (Ex. St. John’s Wort)
• medicines used to manage HIV infections (Ex. ritonavir, saquinavir)
• medicines used to manage depression (Ex. nefazodone)
• medicines used to manage fungal infections (Ex. ketoconazole (except shampoo), fluconazole, voriconazole, miconazole, itraconazole)
• medicines used to control the heartbeat (Ex. amiodarone)
• medicine used to manage organ rejection after transplant (Ex. cyclosporine)
• medicines used to manage high blood pressure/specific heart problems (Ex. diltiazem, verapamil)

B. Drug-Food interaction:

Avoid taking piperine (used as a dietary supplement) while taking MACITENT 10MG TABLET as it may alter the effect of the medicine.

Overdosage:

If you or anyone else accidentally take too much of MACITENT 10MG TABLET, consult your doctor immediately or visit the nearby hospital. Symptoms of overdose are headache, nausea, and/or vomiting.

Synopsis

More Information

• Keep MACITENT 10MG TABLET out of reach of children
• Do not store MACITENT 10MG TABLET above 30°C

FAQs About MACITENT 10MG TABLET

What is MACITENT 10MG TABLET used for?

MACITENT 10MG TABLET is used alone/with other medicines to manage pulmonary hypertension in adults, which is a condition that occurs due to high blood pressure in pulmonary arteries (blood vessels that carry blood from heart to lungs).

What are the common side effects of taking MACITENT 10MG TABLET?

The most common side effects of taking MACITENT 10MG TABLET are anemia, headache, bronchitis (inflammation of the airways), edema (swelling of arms and feet), urinary tract infection, low blood pressure, and/or blocked nose. Consult your doctor if any of these symptoms worsen.

How MACITENT 10MG TABLET works?

MACITENT 10MG TABLET works by blocking the action of endothelin hormone (chemical that cause vasoconstriction) which leads to relaxation and widening of blood vessel wall resulting in reduced pressure on the blood vessel wall and lower blood pressure thus managing pulmonary hypertension in affected individuals.

How MACITENT 10MG TABLET should be taken?

Take MACITENT 10MG TABLET as advised by your physician. Swallow the medicines with a glass of water. Do not crush or chew the medicine. Your physician will decide the correct dose and duration for you depending upon your age, body weight and disease condition.

Can MACITENT 10MG TABLET be used in pregnant women?

No, MACITENT 10MG TABLET is not recommended for use during pregnancy and in women planning for pregnancy.  Women of childbearing potential should use contraceptive measures and should consult doctor immediately if accidental pregnancy occurs while taking MACITENT 10MG TABLET since the medicine may cause harm to the unborn babies.

References

1. Dustin R. Fraidenburg, Ankit A. Desai, and Jason X.-J. Yuan. Treatment of Pulmonary Arterial Hypertension. Goodman & Gilman’s: The Pharmacological basics of Therapeutics. 13th Edition. 2018. Page – 574-584.

2. Anjan Khadka, Dick B Singh Brashier, Anantharamu Tejus, Ashok Kumar Sharma. Macitentan: An important addition to the treatment of pulmonary arterial hypertension. NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. March 2015. [Accessed on 30th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4319253/

3. Nicholas Rothbard, Abhinav Agrawal, Conrad Fischer, Arunabh Talwar, Sonu Sahni. Pulmonary arterial hypertension in the elderly: Clinical perspectives.  NIH National Library of Medicine. National Center for Biotechnology Information. PMC PubMed Central. May 2020. [Accessed on 30th May 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8016023/

4. Janssen Pharmaceutica NV. Electronic Medicines Compendium (EMC). [Revised in July 2022]. [Accessed on 30th May 2022] https://www.medicines.org.uk/emc/files/pil.5223.pdf    

Useful Diagnostic Tests

• Echocardiogram